Manager, QA Evening Shift

Position: Manager, QA Evening 12 hour Shift (6:00pm-6:00am)
** Join Amgen's Mission of Serving Patients*
* At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas
-Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

** Manager, Plant Quality*
* ** What you will do*
* Let's do this. Let's change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function-it's a mindset. We're seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety.

This is more than a role, it's an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.

** Lead Quality. Inspire Excellence. Impact Patients.*
* As a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems.

Key responsibilities include:

· Lead, coach, and develop Quality staff across assigned areas and shifts

· Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements

· Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards

· Review, approve, and oversee key quality systems including:

+ Deviations

+ CAPAs

+ Change Controls

+ Validation documentation

+ Procedures and batch records

· Drive  
** investigations and resolution of deviations** , ensuring timely, thorough, and compliant outcomes

· Ensure  
** production records and test results
** are accurate, complete, and inspection-ready

· Champion and lead  
** continuous improvement initiatives
** to strengthen quality systems and operational performance

· Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders

· Assess and manage  
** quality risks** , escalating critical issues to senior leadership as needed

· Represent QA during  
** internal and external audits and regulatory inspections*
* · Support audit readiness and participate in  
** inspection management activities*
* · Ensure  
** document control excellence** , including ownership and timely periodic review of controlled documents

· Foster a  
** culture of quality, accountability, and compliance
** across all teams

** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

*
* Basic Qualifications:

*
* Doctorate degree

OR

Master's degree and 3 years of quality experience

OR

Bachelor's degree and 5 years of quality experience

OR

Associate's degree and 10 years quality experience

OR

High school diploma / GED and 12 years of quality experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above

*
* Preferred Qualifications:

*
* + Bachelor's degree…